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We have received several recent examples of patients who have had their prescriptions transferred to a pharmacy other than their preferred pharmacy without their knowledge or consent. Has this happened to you?

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Your stories are impactful and extremely helpful so please take a few moments to complete this short survey.

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Problems With Implanted Spinal Cord Stimulators Prompt FDA Action

https://www.medscape.com/viewarticle/936869

Between July 27, 2016, and July 27, 2020, the US Food and Drug Administration (FDA) received a total of 107,728 medical device reports (MDRs) related to implanted spinal cord stimulators (SCSs), including 497 associated with patients’ deaths, 77,937 with patients’ injuries, and 29,294 with device malfunction. If you want to know more about injuries and treatments associated with spinal cord, read here.

As a result, the FDA has sent a letter to healthcare providers reminding them of the importance of conducting a trial stimulation period with patients to confirm adequate pain relief before implanting the device.

Implanted SCSs are used for the management of chronic, intractable pain of the trunk and/or limbs associated with a variety of conditions.

The most frequently reported patient problem ― failure to achieve or maintain adequate pain control (28%) ― highlights the need for patients to undergo and demonstrate an adequate trial stimulation prior to implantation, the FDA says. Other common patient problems included pain (15%), unexpected therapeutic effects (11%), infection (7.5%), and discomfort (6%).

The most frequently reported device problems ― charging problems (11%), impedance (high, low, and/or unspecified, 11%), migration (7%), battery problems (6%), and premature discharge of battery (4%) ― are consistent with those expected with battery-powered stimulation devices intended for longer-term implantation and therapy, the agency notes.

The 497 MDRs coded as a patient death represent 428 unique events reported during the 2016–2020 review period. These events were associated with devices implanted between November 2005 and July 2020.

The patients who died were 69 years old on average and had comorbid conditions, including cancer; chronic diseases, including Parkinson’s disease, diabetes, dementia, and heart disease; and acute illness or injury, including influenza, infection, suicide, and substance abuse.

In roughly 30% of the deaths for which times to event were available, the death occurred within 30 days of implantation. “However, none of the reports provide enough information to conclude that the device caused or contributed to the death,” the FDA says.

On the basis of the MDRs, the FDA recommends that healthcare providers take the following actions:

• Conduct the trial stimulation as described in the device labeling to identify and confirm satisfactory pain relief before permanent SCS implantation.
• Only implant permanent SCSs in patients who have undergone and passed a stimulation trial. A stimulation trial usually lasts 3 to 7 days; success is usually defined as a 50% reduction in pain symptoms. Patients should be informed about the risks for serious side effects and what to expect during the trial stimulation.
• Before implantation of any SCS, discuss with the patient the benefits and risks of the different types of implants and other treatment options; provide the patient with the manufacturer’s patient labeling and any other educational materials for the device that will be implanted; and inform the patient of the risks, benefits, and what to expect during the use of the SCS they will receive.
• Develop an individualized programming, treatment, and follow-up plan for SCS therapy delivery with each patient.
• Provide the patient with the name of the device manufacturer, the model, and the unique device identifier of the implant they received.

Healthcare professionals and consumers can report adverse reactions or quality problems they experience using the devices to the FDA’s MedWatch program.

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AstraZeneca Covid-19 vaccine study put on hold due to suspected adverse reaction in participant in the U.K.

https://www.statnews.com/2020/09/08/astrazeneca-covid-19-vaccine-study-put-on-hold-due-to-suspected-adverse-reaction-in-participant-in-the-u-k/

A large, Phase 3 study testing a Covid-19 vaccine being developed by AstraZeneca and the University of Oxford at dozens of sites across the U.S. has been put on hold due to a suspected serious adverse reaction in a participant in the United Kingdom.

A spokesperson for AstraZeneca, a frontrunner in the race for a Covid-19 vaccine, said in a statement that the company’s “standard review process triggered a pause to vaccination to allow review of safety data.” 

In a follow-up statement, AstraZeneca said it initiated the study hold. The nature of the adverse reaction and when it happened were not immediately known, though the participant is expected to recover, according to an individual familiar with the matter. 

The spokesperson described the pause as “a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials.” The spokesperson also said that the company is “working to expedite the review of the single event to minimize any potential impact on the trial timeline.”

An individual familiar with the development said researchers had been told the hold was placed on the trial out of “an abundance of caution.” A second individual familiar with the matter, who also spoke on condition of anonymity, said the finding is having an impact on other AstraZeneca vaccine trials underway — as well as on the clinical trials being conducted by other vaccine manufacturers.

Clinical holds are not uncommon, and it’s unclear how long AstraZeneca’s might last. But the progress of the company’s trial — and those of all Covid-19 vaccines in development — are being closely watched given the pressing need for new ways to curb the global pandemic. There are currently nine vaccine candidates in Phase 3 trials. AstraZeneca’s is the first Phase 3 Covid-19 vaccine trial known to have been put on hold.

Researchers running other trials are now looking for similar cases of adverse reactions by combing through databases reviewed by a so-called Data and Safety Monitoring Board, the second person said.

AstraZeneca only began its Phase 3 trial in the U.S. in late August. The U.S. trial is currently taking place at 62 sites across the country, according to clinicaltrials.gov, a government registry, though some have not yet started enrolling participants. Phase 2/3 trials were previously started in the U.K., Brazil, and South Africa.

There are a number of different reactions that can qualify as suspected serious adverse reactions, symptoms that require hospitalization, life-threatening illness and even death. It was also not immediately clear which clinical trial the adverse reaction occurred in, though a clear possibility is the Phase 2/3 trial underway in the U.K.

While it’s still unclear how severe and rare the adverse event may be, the finding could impact how quickly efficacy data from the U.K. trial will be available. Those data are considered integral to any bid to seek an emergency use authorization for the vaccine from the U.S. Food and Drug Administration — and potentially jeopardize President Trump’s efforts to fast-track a vaccine ahead of the November election.

A Phase 1/2 study published in July reported that about 60% of 1,000 participants given the vaccine experienced side effects. All of the side effects, which included fever, headaches, muscle pain, and injection site reactions, were deemed mild or moderate. All of the side effects reported also subsided during the course of the study. 

The vaccine  — known as AZD1222 — uses an adenovirus that carries a gene for one of the proteins in SARS-CoV-2, the virus that causes Covid-19. The adenovirus is designed to induce the immune system to generate a protective response against SARS-2. The platform has not been used in an approved vaccine, but has been tested in experimental vaccines against other viruses, including the Ebola virus. 

The Phase 3 trial in the U.S. aims to enroll about 30,000 participants at 80 sites across the country, according to a release last week from the National Institutes of Health. 

It was not immediately clear what steps were being taken at study sites across the U.S. in response to the hold. Clinical holds in ongoing studies often involve a pause in recruiting new participants and dosing existing ones, unless it’s deemed in the interest of participant safety to continue dosing.

In the statement from AstraZeneca, the company spokesperson noted that “in large trials illnesses will happen by chance but must be independently reviewed to check this carefully.” The spokesperson also said the company is “committed to the safety of our participants and the highest standards of conduct in our trials.”

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US Border Patrol agent arrested and charged with trafficking over 350,000 pills believed to be fentanyl

https://www.msn.com/en-us/news/crime/us-border-patrol-agent-arrested-and-charged-with-trafficking-over-350000-pills-believed-to-be-fentanyl/ar-BB17O3E0?ocid=sf

• A US Border Patrol agent assigned to Tucson, Arizona, was arrested and charged with drug trafficking after he was found with thousands of pills and substances that tested positive for cocaine, heroin, and fentanyl.
• Roughly 350,000 pills that tested positive for fentanyl were found in bags that were transferred from the agent’s car.
• Agents found nearly $330,000 in his home and $40,000 in his vehicle.
• Visit Business Insider’s homepage for more stories.

A US Border Patrol agent assigned to Tucson, Arizona, was arrested and charged with drug trafficking after he was found with thousands of pills and substances that tested positive for cocaine, heroin, and fentanyl.

Carlos Victor Passapera Pinnot, 53, left his home around 3:15 a.m. on Sunday and drove to the Phoenix Sky Harbor International Airport, where he placed two duffel bags into another vehicle, the Justice Department said in a press release.

The driver of the second vehicle was stopped by law enforcement officials, and the bags were searched.

The contents included substances that tested positive for an assortment of drugs, including 21 kilograms of cocaine, one kilogram of heroin, and one kilogram of fentanyl. Roughly 350,000 pills that tested positive for fentanyl were found in the bags.

Pinnot was arrested that same day, and his home was searched. Agents found nearly $330,000 in his home and $40,000 in his vehicle, the Justice Department said. The FBI, Department of Homeland Security, and the Drug Enforcement Administration (DEA) took part in the investigation.

If convicted, Pinnot could face a minimum prison sentence of 10 years and a maximum of life in prison.

Other Border Patrol agents have been arrested on charges of possessing drugs. In 2018, a Border Patrol agent based in San Diego, California, was charged with possessing heroin, according to KMGH-TV. Agent Brandon Herrera was found unconscious in a pickup truck parked on the street, law enforcement officials reportedly said at the time.

In a separate incident in 2016, Texas-based US Border Patrol agent Eduardo Baza Jr. was arrested on suspicion of lying about a drug bust nearly a decade earlier, according to KUTV.

Bazan admitted to being a part of a drug ring, one that confiscated authentic cocaine from dealers and then created a watered-down version. That weaker substance was planned to be seized by officials and the stronger drug would be sold in the black market, according to The Dallas Morning News and The McAllen Monitor.

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Iran Caught Stockpiling Enriched Uranium Needed for Bomb

https://freebeacon.com/national-security/iran-caught-stockpiling-enriched-uranium-needed-for-bomb/

The United States has evidence that Iran is stockpiling enriched uranium, the key component in a nuclear weapon, in direct violation of international restrictions on Tehran’s use of the fissile material.

Nuclear experts predict that Iran is now just 3.5 months away from the “breakout time,” a measurement of how close the country is to having the technology and materials to construct a nuclear weapon. It also now has the fuel to potentially construct two separate bombs.

The International Atomic Energy Agency (IAEA) disclosed on Friday that Iran has nearly doubled its stockpiles of enriched uranium, generating concerns about the country’s continued progress on a nuclear weapon. Iran granted the IAEA access to several contested nuclear sites that had previously been off limits. A report on Tehran’s nuclear activities was shared with the United States and other United Nations members.

It is just the latest attempt by Iran to breach restrictions written into the original nuclear agreement governing the amount of uranium it can enrich and keep in the country. Iran has also been building advanced ballistic missiles, contrary to U.N. regulations. The revelations about its uranium enrichment are likely to provide fresh grist for the Trump administration as it seeks to reimpose a set of international sanctions on Iran.

A State Department official, speaking to the Washington Free Beacon only on background, said the IAEA’s report “highlights Iran’s ‘significant nonperformance’ of its commitments under the Iran deal that led the United States to take decisive action to restore U.N. sanctions on Iran.”

The official would not comment on specific claims in the report until it is made public by the IAEA.

However, the official said there is conclusive proof that Iran is violating its commitments under the nuclear deal.

Iran’s enriched uranium store “now exceeds by 10-fold the limit set in the [nuclear deal],” according to the Institute for Science and International Security, a nuclear watchdog group that has closely tracked the IAEA’s inspections. The group said “Iran’s estimated breakout time as of September 2020 is as short as 3.5 months.”

“A new development is that Iran may have enough low enriched uranium to produce enough weapon-grade uranium for a second nuclear weapon, where the second one could be produced more quickly than the first, requiring in total as little as 5.5 months to produce enough weapon-grade uranium for two nuclear weapons,” the group said Friday.

The State Department official said the administration will keep increasing pressure on Iran until it backs away from the pursuit of a nuclear weapon.

“There is no reason for Iran to expand its nuclear program other than to engage in continued brinkmanship,” the official said. “We will continue imposing maximum pressure on the Iranian regime until it ceases its destabilizing activities and negotiates a comprehensive deal. That is why we took decisive action last month to initiate the ‘snapback’ of U.N. sanctions on Iran.”

As part of its pressure campaign at the U.N., the Trump administration has sought to reimpose international sanctions on Iran that were lifted as part of the 2015 nuclear agreement. The success of this effort remains unclear in light of opposition by European powers, as well as Russia and China.

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https://youtu.be/CkdpZvtjxb0

During the 80’s and first part of the 90’s Pharmacists were voted the most respected profession… Independent pharmacies were around 75% of all retail community outlets. By the time that the mid-90’s arrived, the PBM’s and insurance industry because of preferred pharmacy networks – typically excluding independent pharmacies –  and ever reducing reimbursement to pharmacies when filling and billing prescriptions to these entities…  The number of independent pharmacies closing their doors cut the total number of independent pharmacies IN HALF.

Within a few years, Pharmacists dropped down to FOURTH most respected profession. Today independent pharmacies are about 30% of all retail pharmacy outlets.  Could this have been because more and more people were having their prescriptions filled at chain pharmacies and having to deal with Rx dept staffing that is typically BELOW what is considered “skeletal staffing levels”.  I hear of pharmacists either working off the clock to get the backlog of Rxs filled before they can go home or leave 100-200 Rxs left unfilled to greet the pharmacist that opens up the next morning.

It is little wonder that mis-fills/med errors happen… the opening pharmacist and typically one tech… finds enough unfilled Rxs that will take them to at least NOON to get them filled… just to catch up with what should have been done the day before.

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When it comes times to get a COVID-19 vaccine… it is not going to be BUSINESS AS USUAL… The pt can pretty much forget the concept of “service on demand” and the neighborhood pharmacy is going to have to maybe have new freezer/cold storage equipment.  According to this, the vaccine is going to be paid for by the FEDS, and at this point not sure if vendors are going to be allowed to charge for the administration of the vaccine or if insurance will pay for administration.  This may be a “NO WAY” for many pharmacies… having to invest in special freezer storage equipment and the man hours and maintaining a clean vaccination area to meet COVID-19 standards.

‘Mind-bogglingly complex’: Here’s what we know about how COVID vaccine will be distributed when it’s approved

https://www.usatoday.com/story/news/health/2020/09/06/covid-vaccine-complex-distribution-supply-chain-follow-approval/5712053002/

We don’t know when a COVID-19 vaccine will arrive, but we’re starting to know how it will be distributed.

Interviews with logistics experts, immunization professionals and pharmaceutical distribution specialists, together with U.S. Centers for Disease Control and Prevention planning documents, give a clearer picture of how coronavirus vaccines will get from manufacturers into the arms of millions of Americans.

The swift and so far positive effort to create vaccines to fight COVID-19 has been remarkable, but it’s only half of the work, said Tinglong Dai, a professor of operations management who studies health care analytics at the Johns Hopkins University.

“It’s just incredible. I think the vaccine supply chain is one of the most mind-bogglingly complex supply chains ever built,” he said. 

The process will be run by the CDC, which for decades has overseen vaccine distribution in the United States and ran the last national vaccination effort during the 2009 H1N1 influenza pandemic.

“We’re happy to see CDC front and center,” said Dr. Kelly Moore, associate director of immunization education with the Immunization Action Coalition. “They’re the right organization to be leading this.”

All the vaccine supplied in the initial phases will be purchased by the U.S. government, and no one will be charged for the actual dose.

As of early September, it wasn’t clear whether clinics would be allowed to charge an administration fee to those getting their shots. If one was charged, it’s not clear whether insurance could be reimbursed for it if the vaccine is issued under an Emergency Use Authorization, CDC documents say.

At least at the beginning, vaccine is expected to be in short supply, though CDC planning documents say significantly more will be available by January 2021.

The CDC is still finalizing who will be eligible to be vaccinated first, but from meetings of its Advisory Committee on Immunization Practices, it appears front-line medical workers, first responders and people at high risk for severe disease will get first dibs.

Two of the seven vaccine candidates are seen as the front-runners because they are in Phase 3 clinical trials, the make-or-break, large-scale tests in humans that determine whether a vaccine works. 

They are being manufactured by Pfizer and Moderna. The two vaccines must be stored at different temperatures and so will be distributed slightly differently. A third, from AstraZeneca in the United Kingdom, also is in Phase 3 trials but doesn’t appear to be part of CDC’s initial planning scenarios.

An initial vaccination plan

Here’s how it would work: Medical offices, clinics, hospitals, pharmacies and other groups that want to vaccinate people for COVID-19 need to first enroll in the U.S. COVID-19 vaccination program They’ll sign an agreement with the CDC and prove they have the space, the necessary equipment and properly trained staff to administer the shots.

Because the requirements for storing, handling and administering the shots are so challenging, the government will prioritize getting vaccine to sites that can reach large numbers of priority populations and vaccinate lots of people quickly, CDC documents show.

When a vaccine becomes available, a vaccination site will request doses through a state agency, usually its department of public health. That’s how it was generally done during the 2009 nH1N1 influenza pandemic, said Julie Swann, a professor of industrial and systems engineering at North Carolina State University who was a science adviser to the CDC at the time.

The department of health would confirm the site was OK’d to distribute the vaccine. At that point, if vaccine supplies are limited, the state could determine how much vaccine to allocate to that specific site, perhaps less than was requested.

Next, the order will be electronically transmitted to the CDC. The CDC also could decide how many doses to allocated to a given site if vaccine supplies are limited, Moore said.

The CDC will then transmit the order to itscontracted partner McKesson, the largest pharmaceutical distribution and technology company in the United States. It already has distribution centers across the country and is building more for COVID-19.

Vaccine orders will be shipped within 24 hours of approval depending on supply, the CDC’s planning documents say.

National pharmaceutical chains such as Walgreens and CVS could partner directly with the CDC. Military allocations would go through the Department of Defense.

Along with the vaccine, a separate supply kit is to be sent that includes needles, syringes, alcohol prep pads and a small supply of personal protective equipment, including surgical masks and face shields for the staff giving the vaccine.

The devil is in the (freezer) details

Here’s where things diverge a bit. Moderna’s candidate vaccine has to be stored at minus 4 degrees Fahrenheit, but Pfizer’s requires it be stored at minus 94. If either of them are among the first vaccines available, that 90-degree difference means they must be distributed differently.

The Moderna vaccine will be stored either at the manufacturing plant or at a McKesson distribution center. When an order comes in, McKesson will ship it directly to the medical facility that ordered it, said Moore.

The Moderna vaccine comes as a frozen liquid in a 10-dose vial and contains no preservatives. It can be stored in a freezer or in its shipping container if it’s replenished with dry ice, CDC documents show. It can be stored for up to two weeks at normal refrigerator temperatures (36 to 46 degrees) according to data provided by the Immunization Action Coalition. Once at room temperature it must be used within six hours.

After the vial has been punctured to take out the first dose, it is good for six hours and then must be thrown away. Because vaccine will be in short supply, especially at first, clinical sites will need to schedule patients so none is wasted.

To be effective, the Moderna requires two doses of vaccine given 28 days apart. It must be the same vaccine both times.

The Pfizer vaccine is more finicky because of its ultra-low temperature storage requirements, though that may change as more tests are done. Because of the current requirements, the CDC will send orders straight to Pfizer, which will ship to the vaccination sites, Moore said.

The Pfizer vaccine will be shipped in a special transportation container filled with dry ice. The box can be topped off with dry ice every five daysto keep it at the appropriate temperature. The vaccine comes in five-dose vials without preservatives, according to a presentation the company gave to the CDC last week.

The individual vaccine vials can be refrigerated for up to 48 hours but can be held at room temperature for only six hours.

“States are currently surveying their systems to know where their sub-80 (Celsius) freezers are,” Swann said. “I would expect that kind of cold storage to be available at large hospitals, scientific research facilities and some large pharmacies.”

Each of Pfizer’s specially designed transportation containers, which are about the size of a thick pizza box, contains 195 vials, equal to 975 doses. One container can hold five of those boxes, or as many as 4,875 doses.  Because it’s being shipped only in large volumes, the Pfizer vaccine likely would be distributed at larger medical centers or public health departments that have the capacity to vaccinate large numbers of people and have the proper storage facilities on site, Moore said.

Before use, Pfizer’s vaccine will have to be mixed with a special liquid to dilute it, probably something like sterile water. That liquid would be shipped separately. Once it’s mixed it must be used within six hours or discarded, according to the Immunization Action Coalition. It requires two doses given 21 days apart.

Among the other vaccines closest to applying for authorization with FDA, some require refrigeration and at least once can be stored at room temperature. If more than one vaccine is authorized, distribution will depend on how well each works for different populations, said Prashant Yadav, a medical supply chain expert and senior fellow at the Center for Global Development, a think tank in Washington, D.C.

Whatever the timing of an FDA vaccine approval, the complexity of storage, delivery and tracking multiple vaccines with different requirements means states have to be setting up systems today, Moore said. Utilizing services like same day courier in Melbourne can aid in managing these logistical challenges efficiently.

“Planning now allows us to identify the glitches in our process now,” she said. “We can’t wait until a vaccine is approved.”

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Vitamin D Deficiency May Boost COVID-19 Risk

https://www.medscape.com/viewarticle/936928

People who are deficient in vitamin D may be at higher risk of contracting the novel coronavirus than those with sufficient levels, according to the results of a new retrospective study from Illinois.

Individuals with untreated vitamin D deficiency were nearly twice as likely to test positive for COVID-19 relative to their peers with adequate vitamin D levels.

“These findings appear to support a role of vitamin D status in COVID-19 risk,” the authors say in the study, published online September 3 in JAMA Network Open.

“Vitamin D is important to the function of the immune system and vitamin D supplements have previously been shown to lower the risk of viral respiratory tract infections. Our statistical analysis suggests this may be true for the COVID-19 infection,” lead author David Meltzer, MD, PhD, chief of hospital medicine at University of Chicago Medicine, Illinois, said in a news release from his institution. 

Important for Immune Function

Meltzer and colleagues studied 489 University of Chicago Medicine patients (mean age 49 years, 75% women) whose vitamin D levels were determined in the 2 months before being tested for COVID-19. 

Vitamin D deficiency was defined as < 20 ng/mL 25-hydroxycholecalciferol or < 18 pg/mL 1,25-dihydroxycholecalciferol.

Vitamin D status was categorized as likely deficient for 124 participants (25%), likely sufficient for 287 (59%), and uncertain for 78 (16%).

A total of 71 participants (15%) tested positive for COVID-19.

In a multivariate analysis, a positive COVID-19 test was significantly more likely in those with likely vitamin D deficiency than in those with likely sufficient vitamin D levels at the time of COVID-19 testing (relative risk [RR], 1.77; 95% CI, 1.12 – 2.81; P = .02). 

The estimated mean rate of COVID-19 in the deficient group was 21.6% compared with 12.2% in the sufficient group.

Testing positive for COVID-19 was also associated with increasing age up to age 50 years (RR, 1.06; P = .02) and race other than White (RR, 2.54; P = .009)

Protective Effect of Treatment?

The findings also raise the possibility that treatment for vitamin D deficiency may lower the risk of COVID-19, the researchers say.  

Patients with deficient vitamin D levels who had their vitamin D treatment increased did not appear to have increased risk for COVID-19.

This suggests a “protective effect of treatment, but the confidence intervals on estimated rates for these groups are too wide to exclude the possibility of no treatment effect,” Meltzer and colleagues note.

“If vitamin D does reduce COVID-19 incidence, it is tempting to consider whether it might reduce COVID-19 transmission,” they hypothesize.

Because vitamin D strengthens innate immunity it could be expected to decrease COVID-19 infection and transmission. Vitamin D also affects zinc metabolism, which decreases replication of coronaviruses.

As previously reported by Medscape Medical News, a recent study from Israel suggested low plasma vitamin D levels are an independent risk factor for COVID-19 infection and hospitalization.

In that study, participants positive for COVID-19 were 50% more likely to have low vs normal vitamin D levels in a multivariate analysis that controlled for other confounders.

Half of Americans are deficient in Vitamin D, with much higher rates seen in African Americans, Hispanics, and individuals living in areas like Chicago where it is difficult to get enough sun exposure in winter.

“Understanding whether treating Vitamin D deficiency changes COVID-19 risk could be of great importance locally, nationally, and globally,” Meltzer said. “Vitamin D is inexpensive, generally very safe to take, and can be widely scaled.”

Meltzer and colleagues say randomized clinical trials are now needed to see whether broad population interventions and interventions among groups at increased risk of vitamin D deficiency and COVID-19 could reduce COVID-19 cases.

The study was supported by the Learning Health Care System Core of the University of Chicago/Rush University Institute for Translational Medicine (ITM) Clinical and Translational Science Award and the African American Cardiovascular Pharmacogenetics Consortium. The authors have declared no relevant conflicts of interest.

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